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Lesser Tuberosity Osteotomy for Subscapularis Repair

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TSA with tenotomy technique
TSA with lesser tuberosity osteotomy technique
Shoulder prosthesis
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients already scheduled for total shoulder arthroplasty

Exclusion Criteria:

  • Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tenotomy

Osteotomy

Arm Description

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.

Outcomes

Primary Outcome Measures

Number of subjects with radiologic evidence of anatomic healing
Tendon healing/tuberosity union based on radiographs

Secondary Outcome Measures

Change in visual analogue pain scale
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain
Change in dynamometer maximum exertion reading
Strength testing with Dynamometer in forward Flexion, abduction, external rotation and internal rotation using force measurement at max level.
Total Intra-Operative time
To be recorded in minutes, and documented by the surgical team
Total Subscapularis Repair time (in minutes)
To be recorded in minutes, and documented by the surgical team

Full Information

First Posted
April 19, 2016
Last Updated
May 3, 2016
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02762903
Brief Title
Lesser Tuberosity Osteotomy for Subscapularis Repair
Official Title
Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.
Detailed Description
The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in >65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenotomy
Arm Type
Active Comparator
Arm Description
Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.
Arm Title
Osteotomy
Arm Type
Active Comparator
Arm Description
Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.
Intervention Type
Procedure
Intervention Name(s)
TSA with tenotomy technique
Intervention Description
Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.
Intervention Type
Procedure
Intervention Name(s)
TSA with lesser tuberosity osteotomy technique
Intervention Description
Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.
Intervention Type
Device
Intervention Name(s)
Shoulder prosthesis
Intervention Description
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
Primary Outcome Measure Information:
Title
Number of subjects with radiologic evidence of anatomic healing
Description
Tendon healing/tuberosity union based on radiographs
Time Frame
Post operative at 3 months
Secondary Outcome Measure Information:
Title
Change in visual analogue pain scale
Description
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain
Time Frame
Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year
Title
Change in dynamometer maximum exertion reading
Description
Strength testing with Dynamometer in forward Flexion, abduction, external rotation and internal rotation using force measurement at max level.
Time Frame
Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year
Title
Total Intra-Operative time
Description
To be recorded in minutes, and documented by the surgical team
Time Frame
From incision time to time of complete skin closure
Title
Total Subscapularis Repair time (in minutes)
Description
To be recorded in minutes, and documented by the surgical team
Time Frame
From glenoid implantation to completion of tendon or osteotomy repair

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients already scheduled for total shoulder arthroplasty Exclusion Criteria: Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William N. Levine, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lesser Tuberosity Osteotomy for Subscapularis Repair

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